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A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00220922
First received: September 20, 2005
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.


Condition Intervention Phase
Multiple Sclerosis
 Procedure: Alcohol Wipes vs. No Alcohol Wipes
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection [ Time Frame: four weeks of Period 1 and the four weeks of Period 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection [ Time Frame: four weeks of Period 1 and the four weeks of Period 2 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2004
Study Completion Date: February 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
 Procedure: Alcohol Wipes vs. No Alcohol Wipes
Other Name: Copaxone
Experimental: 2
injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
 Procedure: Alcohol Wipes vs. No Alcohol Wipes
Other Name: Copaxone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female
  • 18 years of age or older
  • Diagnosis of RRMS
  • Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously

Exclusion Criteria:

  • Unable to perform subcutaneous self-injection
  • Pregnant, or trying to become pregnant, or breast feeding during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220922

Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
  More Information

Additional Information:
For more information on Multiple Sclerosis  This link exits the ClinicalTrials.gov site
For more information about Teva Neuroscience, Inc.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00220922     History of Changes
Other Study ID Numbers: PM013
Study First Received: September 20, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Copaxone

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Ethanol
Copolymer 1
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2013